BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 9701356 · Received February 12, 2020

    Report

    Report Number
    3004742232-2020-00037
    Event Type
    Injury
    Date Received
    February 12, 2020
    Date of Event
    January 17, 2020
    Report Date
    February 24, 2020
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    UDI-DI
    10852528005046
    PMA / PMN Number
    K190634
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED OAD WAS RECEIVED FOR ANALYSIS. ADHERED BIOLOGICAL MATERIAL WAS OBSERVED ON THE CROWN OF THE OAD. EXAMINATION OF THE AREA OF ADHERED MATERIAL DID NOT REVEAL ANY DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE ACCUMULATION. THE MORPHOLOGY AND EXACT ROOT CAUSE OF THE MATERIAL ACCUMULATION IS UNKNOWN. THERE WAS NO ADDITIONAL DAMAGE OBSERVED ON THE OAD. A GUIDE WIRE WAS PASSED THROUGH THE OAD DRIVESHAFT, INCLUDING THE AREA OF ACCUMULATION, AND OAD HANDLE WITH NO RESISTANCE. THE OAD WAS TESTED, SPUN AT ALL SPEEDS, AND FUNCTIONED AS INTENDED. AT THE CONCLUSION OF THE DEVICE ANALYSIS, THE REPORTED EVENT OF A POSSIBLE PIECE OF INTIMA ON THE OAD CROWN WAS CONFIRMED. THE REPORTED EVENT OF THE OAD SPINNING STOPPING AND BRIEFLY BECOMING STUCK ON THE GUIDE WIRE WERE UNABLE TO BE CONCLUSIVELY CONFIRMED THROUGH ANALYSIS. THE ACCUMULATED MATERIAL MAY HAVE CONTRIBUTED TO THESE REPORTS, HOWEVER, THIS COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. H10: RESULTS CODE: 4247 - SUGGESTED CODE IS BIOLOGICAL MATERIAL PRESENT ON DEVICE. CSI ID#: 08150.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE REPORTED DEVICE IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED TO THE TARGET, 70% STENOSED LESION LOCATED IN AN AREA OF THE PERONEAL ARTERY THAT WAS APPROXIMATELY 3 MILLIMETERS IN DIAMETER. THE TARGET LESION VARIED BETWEEN MILD AND SEVERE CALCIFICATION AND WAS ACCESSED VIA A FEMORAL APPROACH. THE OAD STOPPED SPINNING AS SOON AS IT WAS TURNED ON, AND THERE WERE NO LED LIGHTS LIT ON THE OAD HANDLE. TROUBLESHOOTING WAS ATTEMPTED, BUT THE ISSUE RECURRED. IN THE PHYSICIAN'S OPINION, THE OAD AND GUIDE WIRE WERE NOT SUBINTIMAL AND THE GUIDE WIRE WAS NOT KINKED. THE OAD WAS REMOVED FROM THE PATIENT, AND BRIEFLY BECAME STUCK DURING REMOVAL, HOWEVER, IT THEN WAS REMOVED SMOOTHLY. A POSSIBLE PIECE OF INTIMA WAS OBSERVED ON THE CROWN OF THE OAD. IMAGING WAS PERFORMED, AND A TYPE C DISSECTION WAS PRESENT IN THE PERONEAL ARTERY. BALLOON ANGIOPLASTY, WHICH HAD BEEN ORIGINALLY SCHEDULED, WAS THEN PERFORMED IN THE PERONEAL ARTERY. A SECOND OAD WAS USED TO TREAT ANOTHER LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) SUCCESSFULLY. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161989 STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS, INC. PRD-SC30-150 301869 10852528005046

    Patients

    Seq Age Sex Outcome Treatment
    1 Other